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Pathogen-reduced platelets for the prevention of bleeding

  1. Caroline Butler1,
  2. Carolyn Doree2,
  3. Lise J Estcourt3,
  4. Marialena Trivella4,
  5. Sally Hopewell5,
  6. Susan J Brunskill2,
  7. Simon Stanworth3,
  8. Michael F Murphy6,*

Editorial Group: Cochrane Haematological Malignancies Group

Published Online: 28 MAR 2013

DOI: 10.1002/14651858.CD009072.pub2


How to Cite

Butler C, Doree C, Estcourt LJ, Trivella M, Hopewell S, Brunskill SJ, Stanworth S, Murphy MF. Pathogen-reduced platelets for the prevention of bleeding. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD009072. DOI: 10.1002/14651858.CD009072.pub2.

Author Information

  1. 1

    Oxford Radcliffe Hospital NHS Trust, Haematology Department, Maidenhead, UK

  2. 2

    NHS Blood and Transplant, Systematic Review Initiative, Oxford, UK

  3. 3

    NHS Blood and Transplant, Haematology/Transfusion Medicine, Oxford, UK

  4. 4

    The Cochrane Collaboration, Cochrane Operations Unit, Oxford, UK

  5. 5

    University of Oxford, Centre for Statistics in Medicine, Oxford, Oxfordshire, UK

  6. 6

    John Radcliffe Hospital, NHS Blood and Transplant, Oxford, UK

*Michael F Murphy, NHS Blood and Transplant, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9BQ, UK. mike.murphy@nhsbt.nhs.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 28 MAR 2013

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
Agliastro 2006 {published data only}
  • Agliastro RE, De Francisci G, Bonaccorso R, Spicola D, Ziino O, Arico M, et al. Clinical study in pediatric hemato-oncology patients: efficacy of pathogen inactivated buffy coat platelets versus aphaeresis platelets. Transfusion 2006;46(9s):117A. Abstract No. SP246.
Cazenave 2010 {published and unpublished data}
  • Ambruso DR, Thurman G, Marschner S, Goodrich RP. Lack of antibody formation to platelet neoantigens after transfusion of riboflavin and ultraviolet light-treated platelet concentrates. Transfusion 2009;49(12):2631-6. [PUBMED: 19694996]
  • Goodrich R, Roberts T, Follea G. Clinical evaluation of Mirasol PRT treated apheresis platelets in thrombocytopenic patients. Transfusion 2008;48(Suppl):20A. Abstract No. S49-020G.
  • Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology. Transfusion 2010;50(11):2362-75. [NCT00263809; PUBMED: 20492615]
De Francisci 2004 {published data only}
  • De Francisci G, Bonaccorso R, Bellavia D, D'Alia G, Fiandaca T, Giancana A, et al. Clinical trial on the use of pathogen inactivated platelets, with Helinx® technology, in cardio paediatric surgery and cirrhotic patients. Transfusion 2004;44(s1):17A. Abstract No. S48-0301.
Janetzko 2005 {published and unpublished data}
Kerkhoffs 2010 {published and unpublished data}
  • Kerkhoffs JL, van Putten WL, Novotny VM, Te Boekhorst PA, Schipperus MR, Zwaginga JJ, et al. Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction. British Journal of Haematology 2010;150(2):209-17. [ISRCTN88278819; PUBMED: 20507310]
  • Kerkhoffs JLH, Novotny VM, Te Boekhorst PA, Schipperus MR, Zwaginga JJ, van Pampus L, et al. Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days in either plasma or additive solution with and without pathogen reduction in hemato-oncological patients. Transfusion 2009;49(s3):2A. Abstract No. P5-020A.
Lozano 2011 {published and unpublished data}
  • Lozano M, Knutson F, Tardivel R, Cid J, Maymo RM, Lof H, et al. A multi-center study of therapeutic efficacy and safety of platelet components treated with amotosalen and UVA pathogen inactivation stored for 6 or 7 days prior to transfusion. British Journal of Haematology 2011;153(3):393-401. [PUBMED: 21418180]
McCullough 2004 {published and unpublished data}
  • Benjamin RJ, Goodnough LT, Lopez-Perez I, Strauss R, McCullough J, Slichter S, et al. Fresh (1-2 day-old) vs. aged (4-5 day-old) INTERCEPT platelets and conventional platelets provide comparable count increments. However fresh platelets result in superior hemostasis: results of the SPRINT trial. Transfusion 2003; Vol. 43, issue 9s:9A. Abstract No. S29-030E.
  • Conlan MGC, Vesole DH, Staudtmauer E, Goodnough LT, Coutre S, Howard FD, et al. Source of donor stem cells impacts incidence of bleeding and platelet and RBC transfusion requirements during stem cell transplantation: results of the phase III SPRINT trial of Intercept platelets. Vox Sanguinis 2005; Vol. 89, issue Suppl 2:36-37. Abstract No. 5P-035.
  • Corash L, Eiden J, Lin S. Serious pulmonary adverse events and acute lung injury following repeated platelet transfusions. Transfusion 2008;48(s2):28A. Abstract No. S73-030F.
  • Corash L, Lin JS, Eiden J. Acute lung injury in patients receiving repeated platelet transfusions. Vox Sanguinis 2008; Vol. 95, issue Suppl 1:300-1. Abstract No. P-662.
  • Corash L, Lin JS, Sherman CD, Eiden J. Determination of acute lung injury following repeated platelet transfusions. Blood 2010; Vol. 117, issue 3:1014-20. [PUBMED: 20935256]
  • Goodnough LT, McCullough J, Slichter S, Strauss R, Lin J, Conlan M. A platelet transfusion threshold of 20 x 109/L compared to 10 x 109/L is associated with increased pre-transfusion bleeding and increased platelet transfusions: results of the SPRINT study. Transfusion 2002;42(9s):17S. Abstract No. S62-030K.
  • McCullough J, Vesole D, Benjamin RJ, Slichter S, Pineda A, Snyder E, et al. Pathogen inactivated platelets using Helinx (TM) technology (INTERCEPT) are hemostatically effective in thrombocytopenic patients: The SPRINT trial. Blood 2001;98(11):450a. Abstract No. 1884.
  • McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood 2004;104(5):1534-41. [PUBMED: 15138160]
  • Murphy S, Slichter S, McCullough J, Strauss R, Wood L, Lin J, et al. INTERCEPT platelets are hemostatically as effective as conventional platelets in the prophylaxis and treatment of bleeding: results of the SPRINT trial. Vox Sanguinis 2002;83(109):Abstract No. 329.
  • Murphy S, Snyder E, Cable R, Slichter S, Strauss R, McCullough J, et al. Transfusion of INTERCEPT platelets vs. reference platelets at doses >/=3.0x1011 results in comparable hemostasis and platelet and RBC transfusion requirements. Results of the SPRINT trial. Blood 2003;102(11 Pt 2):815a. Abstract No. 3018.
  • Murphy S, Snyder E, Cable R, Slichter SJ, Strauss RG, McCullough J, et al. Platelet dose consistency and its effect on the number of platelet transfusions for support of thrombocytopenia: an analysis of the SPRINT trial of platelets photochemically treated with amotosalen HCl and ultraviolet A light. Transfusion 2006;46(1):24-33. [PUBMED: 16398727]
  • Pineda A, McCullough J, Benjamin RJ, Cable R, Strauss RG, Burgstaler E, et al. Pathogen inactivation of platelets with a photochemical treatment with amotosalen HCl and ultraviolet light: process used in the SPRINT trial. Transfusion 2006;46(4):562-71. [PUBMED: 16584432]
  • Slichter SJ, Murphy S, Buchholz D, Lin J, Corash L, Conlan M. INTERCEPT platelets (plts) and conventional plts provide comparable hemostatic responses in thrombocytopenic patients: the SPRINT trial. Blood 2002; Vol. 100, issue 11 Pt 2:141b. Abstract No. 4048.
  • Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Lin JS, et al. Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion 2005; Vol. 45, issue 12:1864-75. [PUBMED: 16371039]
  • Strauss RG, Eastlund DT, Lopez-Plaza I, et al. INTERCEPT platelets provided effective hemostasis in thrombocytopenic children: Results of the SPRINT trial. Pediatric Research 2003; Vol. 53, issue 4:287A. Abstract No. 1635.
  • Strauss RG, Slichter S, Lopez-Plaza I, Goodnough LT, McCullough J, Lin J, et al. Intercept platelets exhibit immunologic refractoriness comparable to conventional platelets. Haematologica 2004;89(Suppl 1):Abstract No. 628.
  • Vesole D, Stadtmauer E, Goodnough LT, Coutre S, Howard F, Lin JS, et al. Source of donor stem cells impacts incidence of bleeding and platelet and RBC transfusion requirements during stem cell transplantation (SCT): results of the Phase III SPRINT trial of INTERCEPT pathogen inactivated platelets. Biology of Blood and Bone Marrow Transplantation 2004; Vol. 10, issue 2:233.
Simonsen 2006 {published and unpublished data}
Slichter 2006 {published and unpublished data}
  • Slichter SJ, Corash L, Davis K, Metzel P, Lin L, Buchholz DH. Hemostatic function of photo-chemically treated (PCT) platelets (PLTS) in thrombocytopenic patients. Vox Sanguinis 2000;79(Suppl 1):Abstract No. O102.
  • Slichter SJ, Raife TJ, Davis K, Rheinschmidt M, Buchholz DH, Corash L, et al. Platelets photochemically treated with amotosalen HCl and ultraviolet A light correct bleeding times in patients with thrombocytopenia. Transfusion 2006;46(5):731-40. [PUBMED: 16686840]
van Rhenen 2003 {published and unpublished data}
  • Cazenave JP, Davis K, Corash L. Design of clinical trials to evaluate the efficacy of platelet transfusion: the euroSPRITE trial for components treated with Helinx technology. Seminars in Hematology 2001;38(4 Suppl 11):46-54. [PUBMED: 11727285]
  • Cazenave JP, van Rhenen D, Gulliksson H, Pamphilon D, Ljungman P, Davis K, et al. INTERCEPT buffy coat platelets (IPC) are effective during multiple episodes of thrombocytopenia: the EUROSPRITE trial. Transfusion Clinique et Biologique 2001;8(Suppl 1):132s. Abstract No. P267.
  • Corash L, Cazenave JP, van Rhenen D, Gullikksson H, Pamphilon D, Ljungman P, et al. Platelets treated with HELINX™ technology (HPC) are effective for multiple cycles of transfusion support of thrombocytopenia: the euroSPRITE trial. Transfusion 2001;41(Suppl):38S. Abstract No. S133-040K.
  • Corash L, Klueter H, Rhenen D, Gulliksson H, Pamphilon D, Cazenave JP, et al. Intercept platelet concentrates (LPC) are effective and safe for support of multiple cycles of thrombocytopenia: the EUROSPRITE Phase III Trial. Haematologica 2001;86(Suppl 1):Abstract No. 667.
  • Kluter H, Chapuis B, Cazenave JP, Hastka J, Beris P, Dufour P, et al. Apheresis platelets treated with the INTERCEPT Blood System for pathogen inactivation provide platelet count increments and hemostasis comparable to conventional platelets. Vox Sanguinis 2002;83(110a):Abstract No. 331.
  • Ljungman P, van Rhenen D, Pamphilon D, Metzel P, Marblie S, Lin L, et al. Results of the EUROSPRITE phase III trial: INTERCEPT buffy coat platelet concentrates (IPC) provide effective hemostasis for thrombocytopenic (TCP) patients (pts). Transfusion Clinique et Biologique 2001;8(Suppl 1):100s. Abstract No. P147.
  • Pamphilon D, Buchholz DH, Cazenave JP, Conlan M, Corash L, Davis K, et al. THE EUROSPRITE phase III trial of INTERCEPT buffy coat platelet concentrates (IPC) demonstrates IPC are safe when transfused to thrombocytopenic (TCP) patients (PTS). Transfusion Clinique et Biologique 2001;8(Suppl 1):100-1s. Abstract No. P148.
  • Sintnicolaas K, Flament J, Corash L, van Rhenen D. Clinical refractoriness and HLA alloimmunisation are infrequent after multiple exposures to INTERCEPT-TM platelets. Transfusion Clinique et Biologique 2001;8(Suppl 1):100s, 133s. Abstract No. P146 & P269.
  • van Rhenen D, Gulliksson H, Cazenave JP, Pamphilon D, Ljungman P, Kluter H, et al. Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial. Blood 2003;101(6):2426-33. [PUBMED: 12456508]
  • van Rhenen D, Gulliksson H, Pamphilon D, Cazenave JP, Ljungman P, Davis K, et al. S-59 (Helinx™) photochemically treated platelets (plt) are safe and effective for support of thrombocytopenia: results of the Eurosprite phase 3 trial. Blood 2000;96(11):819a. Abstract No. 3539.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
Ambruso 2009 {published data only}
Andreu 1993 {published data only}
  • Andreu G, Norol F, Schooneman F, Coffe C, Pouthier F, Soulier J, et al. Prevention of HLA alloimmunization using UV-B irradiated platelet concentrates (PC): results of a prospective randomized clinical trial. Transfusion 1993;33(9s):73S. Abstract No. S283.
AuBuchon 2005 {published data only}
  • AuBuchon JP, Herschel L, Roger J, Taylor H, Whitley P, Li J, et al. Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion 2004;44(s1):16A-17A. Abstract No. S47-0301.
  • AuBuchon JP, Herschel L, Roger J, Taylor H, Whitley P, Li J, et al. Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion 2005;45(8):1335-41. [PUBMED: 16078923]
Blundell 1996 {published data only}
Corash 2000 {published data only}
  • Corash LM, Paton V, Wages D, Rheinschmidt M, Porter S, Cimino G, et al. S-59 clearance and kinetics after transfusion of platelets treated with Helinx™ technology. Transfusion 2000;40(Suppl):37S. Abstract No. S137-040I.
Dumont 2010 {published data only}
  • Dumont LJ, Dumont DF, Unger ZM, Siegel A, Szczepiorkowski ZM, Corson JS, et al. A randomized controlled trial comparing autologous radiolabeled in vivo platelet recoveries and survivals of 7-day stored PRP and buffy coat platelets from the same donors. Transfusion 2010;50(s2):1A-2A. Abstract P3-020A.
TRAP 1997 {published data only}
  • TRAP Study Group. Leukocyte reduction and ultraviolet B irradiation of platelets to prevent alloimmunization and refractoriness to platelet transfusions. The Trial to Reduce Alloimmunization to Platelets Study Group. New England Journal of Medicine 1997;337(26):1861-9. [PUBMED: 9417523]

References to studies awaiting assessment

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
Johansson 2012 {published data only}
  • Johansson PI, Simonsen A, Ostrowski SR, Deberdt L, Marschner S, Goodrich R. TEG as a surrogate marker for the haemostatic function of PRT treated platelets in thrombocytopenic patients. Transfusion 2012;52(Suppl 3):67A. Abstract No. SP34.
  • Johansson PI, Simonsen AC, Brown PN, Ostrowski SR, Deberdt L, Van Hoydonck P, et al. A pilot study to assess the hemostatic function of pathogen-reduced platelets in patients with thrombocytopenia. Transfusion 2012 [Epub ahead of print, Dec 24]. [NCT01368211; PUBMED: 23278371]

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
Kerkhoffs 2013 {unpublished data only}
  • Kerkhoffs JLH. Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in acute myeloid leukemia patients (PREPAReS Study - Pathogen Reduction Evaluation & Predictive Analytical Rating Score). Nederlands Trial Register Date accessed February 2013. [NTR2106]
Rebulla 2009 {unpublished data only}
  • Rebulla P, Grazzini G, Liumbruno GM, Aprili G, Formisano S, Girelli G, et al [The Italian Pathogen reduction Technology Assessment Study (IPTAS) Research Group]. Pathogen inactivated platelets and prevention of immunological adverse reactions: the Italian Platelet Technology Assessment Study (IPTAS). Blood Transfusion. 2009; Vol. 7, Suppl 1: 11th European Haemovigilance Seminar:Abstract No. LE08. (Abstract freely available at: http://www.bloodtransfusion.it/articoli/47/en/Doi%200013.pdf. Date accessed: 18 February 2013). [DOI: 10.2450/2009.0013-09]
Tiberghien 2013 {unpublished data only}
  • Tiberghien P, Garban F. Evaluation of the efficacy of platelets treated with pathogen inactivation process (EFFIPAP). ClinicalTrials.gov. Date accessed: 18 February 2013.

Additional references

  1. References to studies included in this review
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  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
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Blajchman 2006
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  • Cazenave JP, Isola H, Waller C, Mendel I, Kientz D, Laforêt M, et al. Use of additive solutions and pathogen inactivation treatment of platelet components in a regional blood center: impact on patient outcomes and component utilization during a 3-year period. Transfusion 2011;51:622-9.
Ciaravino 2003
Cid 2012
  • Cid J, Escolar G, Lozano M. Therapeutic efficacy of platelet components treated with amotosalen and ultraviolet A pathogen inactivation method: results of a meta-analysis of randomized controlled trials. Vox Sanguinis 2012; Vol. 103, issue 4:322-30.
Cook 2012
  • Cook RJ, Heddle NM. Clinical trials evaluating pathogen-reduced platelet products: methodologic issues and recommendations. Transfusion 2012 [Epub ahead of print, Nov 12].
Deeks 2011
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Goodnough 2003
Goodrich 2006
  • Goodrich RP, Edrich RA, Li J, Seghatchian J. The Mirasol PRT system for pathogen reduction of platelets and plasma: an overview of current status and future trends. Transfusion and Apheresis Science 2006;35(1):5-17.
Grass 1998
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Hardwick 2004
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Janetzko 2002
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Kumar 2004
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Snyder 2004
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Tice 2007
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